cervix cancer research network (ccrn) slides mcc ccrn j... · •4th most common cancer women...

Cervix Cancer Research Network (CCRN)

Chair: Mary McCormackSteering Committee: Marie Plante, David Gaffney, Sang Young Ryu, Bill

Small, Jonathan Berek, CarienCreutzberg, Anuja Jhingran, Linus

Chuang ,Linda Mileshkin, Al Covens (IGCS) and Monica Bacon

Gynecologic Cancer InterGroup

Cervix Cancer Research Network

Cervix Cancer Education Symposium, January 2019, South Africa

• 4th most common

cancer women

• Over 500,000 new

cases/260,000 deaths

per year

• Mortality varies 2-

27/100,000

• Cancer burden likely to

rise

Global Cancer Statistics, 2012. CA Cancer J Clin;65-87-108, 2015




Gynecologic Cancer InterGroupCervix Cancer Research Network

Lancet 2017,389


Cervical cancer

challenges

Access to care

National

Regional

local

Financial & social

Quality of care

Outcome & survivorship




Cervical Cancer

LMIC where disease burden

greatest

High income countries

publically funded cervical cancer

trials




What is CCRN ?

• A Network of centres with expertise in the management of cervical cancer

• Established in 2011 by Prof Henry Kitchner & managed by GCIG

• These centres are generally in LMIC

• Common goal to promote research and good clinical practice in the treatment of women with cervical cancer

• Recognised that participation in research raises the standards for all patients.

• Inclusion of patients from diverse ethical and cultural backgrounds in clinical trials is essential to validate potentially practice changing approaches.




CCRN background

GCIG established 1993

Currently comprises 29 cooperative groups

Main mission is to promote academic trials in Gyn cancer

Interested sites in areas where national cooperative groups not yet established

CCRN




Current CCRN studies

SHAPE (NCIC)

SENTICOL III(GINECO)

EARLY STAGE

DISEASEINTERLACE (NCRI)

TACO (KGOG)

Hypofrac

LOCALLY ADVANCED




CCRN standard operating procedure

Expression of interest

Documentation of Resources &

Research

Capability

Remote RTQA (+/- Site visit)




Resources & Research Capability• Site information-contacts/ number of new cancers, Gyn ca & Cervix

• Site resources-pathology/radiology/ IT/ indemnity insurance

• Clinical trials ops-CTU/Personnel /tumour boards/ previous trials experience/details of ethics and regulatory approval processes

• Radiation therapy –facilities/documentation/dosimetry audit




CCRN trials-Capability questionnaire

1. Are your clinical trial subjects entitled to medical management without cost as long as required; and entitled to financial compensation for clinical trial related injury or death?

2. Do you have (national) definitions of what constitutes 'clinical trial related injury or death'?

3. Do you follow ICH Good Clinical Practice [GCP] Guidelines?

4. As well as protocol-mandated reporting through the data reporting mechanism, is there a national regulatory procedure for reporting serious adverse events .




Rio

Salvador

Sao Paulo

Cuba

Honduras

Lima

INDIA

Mumbai

Bangalore

Trivandrum

Saroj Gupta Kolkata

CNCI Kolkata

AIIMS (New Delhi)

TATA Kolkata

Vietnam

Thailand

MinskMoscow (3)

CHINA

Chengdu

Hangzhou

Blue- participating in current trialsRed - CCRN approvedGold- approved with contingencyBlack- pending


Cluj

Current CCRN sites


Meeting objectives

• Establish new partnerships to further care of women with cervical cancer

• Facilitate the exchange of ideas in developing new trials

• Encourage participation in ongoing CCRN trials

• Understand HIV & Cervical cancer and its unique challenges






With thanks to our sponsors & supporters.


END

Cervix Cancer Education Symposium, February 2018

International clinical trials-Challenges

Infrastructure & communication

•Language barriers

•Translation & verification of docs

Contract negotiations

• Insurance & indemnification

•Provision to cover standard of care treatment

time

•Regulatory approvals

• Impact on accrual targets

•cost



cervix cancer research network (ccrn) slides mcc ccrn j... · •4th most common cancer women...

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